UMIN-CTR Clinical Trial

Basic information
Public title	Study of music therapy in Integrative Medicine
Acronym	Performance and evaluation of music therapy
Scientific Title	Trial of music therapy for the subjects
Scientific Title:Acronym	Trial of music therapy
Region	Japan

Condition
Condition	Healthy and various diseases
Classification by specialty	Medicine in general Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical effect of music
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL, ADL, vitals, markers of five senses and several factors related to music and medicine (baseline and 12 weeks later, evaluated factors include various biomarkers)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjectives with no remarkable problems of QOL/ADL
Key exclusion criteria	Subjectives with remarkable problems of QOL/ADL
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Bando
Organization	Medical research
Division name	Medical and music division
Zip code	7700943
Address	Nakashowa 1-61, Tokushima, Japan
TEL	09031872485
Email	pianomed@bronze.ocn.ne.jp

Public contact
Name of contact person	1st name HIROSHI Middle name Last name BANDO
Organization	Medical research/Tokushima Univ
Division name	Medical and music division
Zip code	770
Address	Nakashowa 1-61, Tokushima 770-0943 JAPAN
TEL	819031872485
Homepage URL
Email	pianomed@bronze.ocn.ne.jp

Sponsor
Institute	Medical research
Institute
Department

Funding Source
Organization	Medical research
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical research
Address	Nakashowa 1-61, Tokushima, Japan
Tel	09031872485
Email	pianomed@bronze.ocn.ne.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2026 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Collaboration with other research of music therapy and medical practice

Management information
Registered date	2022 Year 07 Month 28 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055275

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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